Hearing preservation in cochlear implantation surgery

Recruiting

• Conditions: Deafness; sensory neuronal hearing loss; 10019243

• Registration Number: NL-OMON49726
• Lead Sponsor: niversitair Medisch Centrum Utrecht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 18 June 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 48

Inclusion Criteria

- Severe hearing loss, CI candidate
- 18 years of age or older
- normal function of middle ear (i.e. no acute middle ear infections)
- dutch language proficiency
- choice for Advanced Bionics implant

Exclusion Criteria

- prior otologic surgery in the implanted ear (excluding tympanostomy tube
placement)
- inner ear malformation present in the ear to be implanted (i.e. ossification,
Mondini malformation)
- retrocochlear pathology present in the auditory system to be implanted
- neurocognitive disorders
- sudden deafness

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Hearing preservation is the main outcome, which will be expressed in<br /><br>percentage. Hearing preservation is calculated by using the preoperative and<br /><br>postoperative puretoneaudiometry (PTA). </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Scalar position of the electrode array (scala tympani or scala vestibuli<br /><br>assessed by CB-CT), ECochG (among others amplitude in µV) and eCAP (among<br /><br>others amplitude in µV) potentials, and speech perception test with/without<br /><br>noise in CVC words correct score (in percentage) with signal to noise ratio of<br /><br>10 dB. </p><br>